Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145652
Status:
COMPLETED
Last Update Posted:
2007-07-30
First Post:
2005-09-01
Brief Title:
Adjuvant IV Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders
Sponsor:
Sundsvall Hospital
Organization:
Sundsvall Hospital
Study Overview
Official Title:
Phase 3 Study of Recombinant Erythropoetin and Adjuvant IV Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open label randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied The study will be performed according to the ICH-GCP guidelines In order to be eligible the patient must consent in writing that heshe agrees to participate in the study The patient recruitment period is estimated to be no longer than 18 months
Detailed Description:
In this multi-center randomized open label phase-3 study the correction of mild or moderate anemia and the effect on iron kinetics by rHuEPO treatment with or without intravenous iron treatment in patients with LPD not receiving antineoplastic therapy will be studied
LENGTH OF STUDY 16 weeks
NUMBER OF CENTERS 15
NUMBER OF SUBJECTS 66
STRATIFICATION 1 According to diagnosis CLL and indolent NHL vs MM 2 According to level of S-epo 100 IUL vs 100 IUL at baseline
TREATMENT The patients will be randomized to receive 30 000 IU Neorecormon â epoetin beta sc once week for 16 consecutive weeks - 100mgweek of Venofer â iron sucrose from week 0 to 6 followed by one 100mg dose every 2 week from weeks 8 until 14
If the increase in Hb concentration is less than 10gL from baseline week 0 until week 4 weeks the dose of epoetin beta will be increased to 60 000 IU weekly from week 5
If the Hb concentration exceeds 140 gL the epoetin beta therapy will be suspended The treatment will be resumed once the Hb concentration falls below 130 gL This resumed dose will be 75 of the previous dose eg if the previous dose was 30 000 IU before suspension the continued dose should be 22 500 IU If the dose was 60 000 IU before suspension the dose should be 45 000 IU
If the level of S-ferritin reaches 1000 ugL iron sucrose should be suspended until the S-ferritin level falls below 500 ugL
LENGTH OF STUDY 16 weeks
NUMBER OF CENTERS 15
NUMBER OF SUBJECTS 66
STRATIFICATION 1 According to diagnosis CLL and indolent NHL vs MM 2 According to level of S-epo 100 IUL vs 100 IUL at baseline
TREATMENT The patients will be randomized to receive 30 000 IU Neorecormon â epoetin beta sc once week for 16 consecutive weeks - 100mgweek of Venofer â iron sucrose from week 0 to 6 followed by one 100mg dose every 2 week from weeks 8 until 14
If the increase in Hb concentration is less than 10gL from baseline week 0 until week 4 weeks the dose of epoetin beta will be increased to 60 000 IU weekly from week 5
If the Hb concentration exceeds 140 gL the epoetin beta therapy will be suspended The treatment will be resumed once the Hb concentration falls below 130 gL This resumed dose will be 75 of the previous dose eg if the previous dose was 30 000 IU before suspension the continued dose should be 22 500 IU If the dose was 60 000 IU before suspension the dose should be 45 000 IU
If the level of S-ferritin reaches 1000 ugL iron sucrose should be suspended until the S-ferritin level falls below 500 ugL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Dnr151200329970 | None | None | None |
| Medical Products Agency | None | None | None |